System, apparatus, and method for monitoring and assessing the level of fetal risk during labor

Abstract

An apparatus has a computer receiving input signals indicative of fetal heart rate (“FHR”) and maternal uterine activity in a patient. The computer determines when each of FHR, baseline FHR variability, FHR accelerations, FHR decelerations, and maternal uterine activity exhibit a plurality of pre-defined non-reassuring characteristics. The computer receives inputs indicating the presence of maternal, obstetrical, and fetal risk factors, and determines at predetermined times during labor a present level of risk to the fetus which accounts for the total of the number of parameters that each exhibit the non-reassuring characteristics at predetermined points in time during labor and the number of risk factors present. An output display depicts in a single graphical interface information respecting the parameters and risk factors over time during labor. The graphical interface includes indicia for indicating the present level of fetal risk at the predetermined times during labor and signals the need for intervention.

The invention in which an exclusive property or privilege is claimed is defined as follows: 
     
       1. An apparatus for identifying the level of fetal risk during labor, the apparatus comprising:
 at least one computer operative to receive input signals indicative of at least fetal heart rate (“FHR”) and maternal uterine activity in a patient, the at least one computer further operative (i) to determine from the FHR at least baseline FHR variability, FHR accelerations, and FHR decelerations, and (ii) to determine when each of at least (a) FHR, (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity exhibit at least one non-reassuring characteristic from among a plurality of pre-defined non-reassuring characteristics for at least the parameters (a) through (e); 
 wherein the at least one computer is further operative to:
 (iii) receive inputs indicative of the presence in the patient of one or more parameters in the form of (f) maternal risk factors, (g) obstetrical risk factors, and (h) fetal risk factors distinct from the parameters (a) through (d) which elevate the level of fetal risk during labor; and 
 (iv) to determine at predetermined points in time during labor a present level of risk to the fetus which takes into account only the total of the number of the parameters (a) through (e) that each simultaneously, independently exhibit at least one of the non-reassuring characteristics at each predetermined point in time during labor and the number of the parameters (f) through (h) which are present; 
 
 at least one output operatively connected to the at least one computer, the at least one output comprising a display which depicts in a single graphical user interface information respecting one or more of the parameters (a) through (h) over time during labor, and the appearance of which single graphical user interface includes indicia for indicating the determined present level of risk to the fetus at the predetermined points in time during labor and signaling the need for possible intervention in labor; 
 wherein the single graphical user interface displays said information over the entire period of time during which input signals indicative of at least FHR and maternal uterine activity in a patient are received by the at least one computer, which period of time continues at least to delivery; and 
 said information being successively displayed as to discrete segments of time, one after the other, as the period of time during which the input signals are received increases, and said information for each discrete segment of time being persistently displayed such that the information displayed as to each discrete segment of time remains displayed in the single graphical interface as information for each successive discrete segment of time is displayed, whereby the information displayed at any given point in the period of time during which the input signals are received comprehends information for all discrete segments of time from the beginning of the period of time during which the input signals are received and continuing to the given point in time. 
 
     
     
       2. The apparatus of  claim 1 , wherein the highest determined level of risk to the fetus corresponds to any combination of the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the one or more parameters (f) through (h) which are present. 
     
     
       3. The apparatus of  claim 1 , wherein the at least one computer is further operative to identify a predetermined action to be taken in response to the indicated present level of risk to the fetus. 
     
     
       4. The apparatus of  claim 1 , wherein the maternal risk factors (f) are one or more from the group consisting of: decreased cardiac output/vascular perfusion of the placenta; diminished oxygen carrying capacity; chronic or acute infection; chronic debilitating disease; malabsorption/poor weight gain; endocrine disorders; advanced maternal age; drug abuse, drug addiction, and/or smoking; BMI >35; and a stature that is ≤5′2″. 
     
     
       5. The apparatus of  claim 1 , wherein the obstetrical risk factors (g) are one or more from the group consisting of: IUGR/Macrosomia; Oligohydramnios; Polyhydramnios; Bleeding and abruption; Previous cesarean section; Placental and umbilical cord anomalies; Rupture of membranes (PPROM, SROM, AROM); Dystocia (protraction and arrest disorders of labor); and Malpresentation. 
     
     
       6. The apparatus of  claim 1 , wherein the fetal risk factors (h) are one or more from the group consisting of: Abnormal Dopplers/BPP; Genetic disorders; Fetal arrhythmia; Meconium passage; Chorioamnionitis; Second stage of labor; Amnioinfusion; Discontinuation of Pitocin due to fetal intolerance; acute prolonged tachycardia (>170 bpm); Ominous overshoots; Bradycardia (<100 bpm); lack of EFM in second stage. 
     
     
       7. The apparatus of  claim 1 , wherein the at least one non-reassuring characteristic for each of the parameters (a) through (e) is selected from the following: (a) for FHR: any of (i) a fetal heart rate of over 160 bpm or (ii) a fetal heart rate of less than 120 bpm; (b) for baseline FHR variability: any of (i) a variability of more than 15 bpm or (ii) a variability of less than 5 bpm; (c) for FHR accelerations: any of (i) the occurrence of less than two accelerations in 10 minutes of 15 bpm for at least 15 seconds, (ii) the absence of shoulders, or (iii) the presence of overshoots; (d) for FHR decelerations: any of (i) late decelerations, (ii) variable decelerations with slow return to baseline FHR, (iii) the presence of overshoots, or (iv) prolonged FHR deceleration; and (e) for maternal uterine activity: any of (i) repetitive contractions in excess of  5  uterine contractions in  3  consecutive 10 minute windows, (ii) a uterine resting tone of greater than 25 mm Hg, (iii) a contraction duration of greater than 90 seconds, (iv) the coupling or tripling of contractions prior to return to baseline, or (v) a contraction duty cycle of greater than 50%. 
     
     
       8. The apparatus of  claim 1 , wherein a highest determined level of risk to the fetus corresponds to any combination of the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the one or more parameters (f) through (h) which together total seven or eight. 
     
     
       9. The apparatus of  claim 8 , wherein a lowest determined level of risk to the fetus corresponds to any combination of the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the one or more parameters (f) through (h) which together total four or fewer. 
     
     
       10. The apparatus of  claim 9 , wherein a determined level of risk between the lowest and highest determined levels of risk to the fetus corresponds to any combination of the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the one or more parameters (f) through (h) which together total five or six. 
     
     
       11. The apparatus of  claim 1 , wherein the indicia signaling the need for possible intervention in labor comprise one or more colors. 
     
     
       12. The apparatus of  claim 11 , wherein the indicia signaling the need for possible intervention in labor comprise a first color when the determined level of risk is a lowest determined level of risk, a second color when the determined level of risk is between the lowest determined level of risk and a highest determined levels of risk, and a third color when the determined level of risk is the highest determined level of risk. 
     
     
       13. The apparatus of  claim 12 , wherein the graphical user interface further persistently depicts one of the first, second, or third colors for each of the said discrete segments of time. 
     
     
       14. A method for identifying the level of fetal risk during labor, the method comprising:
 providing the apparatus as recited in  claim 1 ; 
 monitoring fetal heart rate (“FHR”) and maternal uterine activity in a patient; 
 determining via the at least one computer at least: baseline FHR variability, FHR accelerations, and FHR decelerations, and determining via the at least one computer when each of at least (a) FHR, (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity exhibit at least one non-reassuring characteristic from among a plurality of pre-defined non-reassuring characteristics for at least the parameters (a) through (e); 
 determining the presence in the patient of any one or more of the parameters (f)-(h); 
 providing to the at least one computer inputs indicative of the presence in the patient of the parameters (f)-(h) determined to be present in the patient; 
 determining via the at least one computer at predetermined points in time during labor a present level of risk to the fetus which takes into account only the total of the number of the parameters (a) through (e) that each simultaneously, independently exhibit at least one of the non-reassuring characteristics at each predetermined point in time during labor and of the number of the parameters (f) through (h) which are present; 
 providing via the at least one output a display which depicts in a single graphical user interface information respecting one or more of the parameters (a) through (h) over time during labor and continuing at least to delivery, and the appearance of which single graphical user interface includes indicia for indicating the determined present level of risk to the fetus at the predetermined points in time during labor and signaling the need for possible intervention in labor, wherein the single graphical user interface displays said information over the entire period of time during which input signals indicative of at least FHR and maternal uterine activity in a patient are received by the at least one computer; and 
 said information being successively displayed as to discrete segments of time, one after the other, as the period of time during which the input signals are received increases, and said information for each discrete segment of time being persistently displayed such that the information displayed as to each discrete segment of time remains displayed in the single graphical interface as information for each successive discrete segment of time is displayed, whereby the information displayed at any given point in the period of time during which the input signals are received comprehends information for all discrete segments of time from the beginning of the period of time during which the input signals are received and continuing to the given point in time. 
 
     
     
       15. The method of  claim 14 , wherein the highest determined level of risk to the fetus corresponds to any combination of the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the parameters (f) through (h) which are present. 
     
     
       16. The method of  claim 14 , wherein the at least one computer is further operative to identify a predetermined action to be taken in response to the indicated present level of risk to the fetus. 
     
     
       17. The method of  claim 14 , wherein the maternal risk factors (f) are one or more from the group consisting of: decreased cardiac output/vascular perfusion of the placenta; diminished oxygen carrying capacity; chronic or acute infection; chronic debilitating disease; malabsorption/poor weight gain; endocrine disorders; advanced maternal age; drug abuse, drug addiction, and/or smoking; BMI >35; and a stature that is ≤5′2″. 
     
     
       18. The method of  claim 14 , wherein the obstetrical risk factors (g) are one or more from the group consisting of: IUGR/Macrosomia; Oligohydramnios; Polyhydramnios; Bleeding and abruption; Previous cesarean section; Placental and umbilical cord anomalies; Rupture of membranes (PPROM, SROM, AROM); Dystocia (protraction and arrest disorders of labor); and Malpresentation. 
     
     
       19. The method of  claim 14 , wherein the fetal risk factors (h) are one or more from the group consisting of: Abnormal Dopplers/BPP; Genetic disorders; Fetal arrhythmia; Meconium passage; Chorioamnionitis; Second stage of labor; Amnioinfusion; Discontinuation of Pitocin due to fetal intolerance; acute prolonged tachycardia (>170 bpm); Ominous overshoots; Bradycardia (<100 bpm); lack of EFM in second stage. 
     
     
       20. The method of  claim 14 , wherein the at least one non-reassuring characteristic for each of the parameters (a) through (e) is selected from the following: (a) for FHR: any of (i) a fetal heart rate of over 160 bpm or (ii) a fetal heart rate of less than 120 bpm; (b) for baseline FHR variability: any of (i) a variability of more than 15 bpm or (ii) a variability of less than 5 bpm; (c) for FHR accelerations: any of (i) the occurrence of less than two accelerations in 10 minutes of 15 bpm for at least 15 seconds, (ii) the absence of shoulders, or (iii) the presence of overshoots; (d) for FHR decelerations: any of (i) late decelerations, (ii) variable decelerations with slow return to baseline FHR, (iii) the presence of overshoots, or (iv) prolonged FHR deceleration; and (e) for maternal uterine activity: any of (i) repetitive contractions in excess of  5  uterine contractions in  3  consecutive 10 minute windows, (ii) a uterine resting tone of greater than 25 mm Hg, (iii) a contraction duration of greater than 90 seconds, (iv) the coupling or tripling of contractions prior to return to baseline, or (v) a contraction duty cycle of greater than 50%. 
     
     
       21. The method of  claim 14 , wherein a highest determined level of risk to the fetus corresponds to any combination of the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the one or more parameters (f) through (h) which together total seven or eight. 
     
     
       22. The method of  claim 21 , wherein a lowest determined level of risk to the fetus corresponds to any combination of the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the parameters (f) through (h) which together total four or fewer. 
     
     
       23. The method of  claim 22 , wherein a determined level of risk between the lowest and highest determined levels of risk to the fetus corresponds to any combination of the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the parameters (f) through (h) which together total five or six. 
     
     
       24. The method of  claim 14 , wherein the indicia signaling the need for possible intervention in labor comprise one or more colors. 
     
     
       25. The method of  claim 24 , wherein the indicia signaling the need for possible intervention in labor comprise a first color when the determined level of risk is a lowest determined level of risk, a second color when the determined level of risk is between the lowest and a highest determined levels of risk, and a third color when the determined level of risk is the highest determined level of risk. 
     
     
       26. The method of  claim 25 , wherein the graphical user interface further persistently depicts one of the first, second, or third colors for each of the said discrete segments of time. 
     
     
       27. The method of  claim 14 , wherein the step of providing an apparatus according to  claim 1  further comprises that the single graphical user interface provides, for each discrete segment of time for which information is displayed, discrete areas for the display of each of maternal, fetal, and obstetrical information. 
     
     
       28. A method for determining the present level of risk to a fetus during labor, and for displaying information related to and facilitating the identification of the level of fetal risk during labor on a single graphical user interface, the method comprising:
 providing the apparatus according to  claim 1 ; 
 at the conclusion of each of a plurality of predetermined periods of time during labor and continuing at least to delivery, determining via the at least one computer the present level of risk to the fetus, and displaying on the single graphical user interface for the just-concluded period of time at least indicia corresponding to the determined present level of risk to the fetus for the just-concluded period of time, and wherein the indicia for each just-concluded period of time are successively displayed, one after the other, as the number of the plurality of predetermined periods of time increases, and wherein further the indicia for each just-concluded period of time are persistently displayed on the single graphical user interface as the number of the plurality of predetermined periods of time increases such that the indicia displayed as to each just-concluded period of time remains displayed in the single graphical interface as indicia for each successive one of the plurality of periods of time is displayed. 
 
     
     
       29. The method of  claim 28 , wherein the step of providing an apparatus according to  claim 1  further comprises that the single graphical user interface provides, for each discrete segment of time for which information is displayed, discrete areas for the display of each of maternal, fetal, and obstetrical information. 
     
     
       30. The apparatus of  claim 1 , wherein further the single graphical user interface provides, for each discrete segment of time for which information is displayed, discrete areas for the display of each of maternal, fetal, and obstetrical information.